This position will drive cleaning, disinfection, and sterilization validation(s) for new and modified surgical medical devices. This position requires knowledge of a variety of sterilization methods including Ethylene Oxide, autoclave, and Vaporized Hydrogen Peroxide. The Microbiologist should have the ability to prepare and communicate validation schedules and coordinate with contract sterilization vendors.
This position will drive the planning, scheduling, and execution of biocompatibility testing for surgical medical devices. A working knowledge of the application of ISO 10993 is required including the interpretation of biocompatibility test results.
The position provides technical guidance to engineers and/or project management. The Microbiologist should possess strong protocol development and report development for inclusion within FDA submissions.
Manage technical projects through contract development, protocol development, laboratory testing, data analysis, and final report generation.
Provide technical support for new product development and manufacturing processes related to microbiological quality.
Perform duties in compliance with Quality System, environmental, health and safety related site rules, policies, standards, or governmental regulations.
Assist in the development of sterilization contracts with contract sterilizers and contract manufacturers. Audit contract manufacturers for sterilization processes and production records.
Develop and coordinate autoclave, EO, and VHP studies.
Develop and coordinate reusable device validation (Disinfection, Cleaning Studies).
Advise on microorganisms as they relate to the cleaning, disinfection, and sterilization of reusable medical devices.
Advise on microorganisms as they relate to the terminal sterilization of single use medical devices.
Review laboratory protocols for accuracy, consistency, and compliance with applicable standards.
Perform necessary testing and analyze data.
Report findings in a clear and concise manner conforming to company formats.
Trend data to ensure continued compliance.
Perform laboratory equipment validations (autoclave, VHP). Support the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ) for terminally sterilized products.
Acts as technical advisor for contract manufacturers and projects regarding sterilization, contamination control, GLP, process qualification, and test documentation.
Review and revise manufacturing related documents, protocols, and procedures; assure manufacturing needs are met.
Work closely with R&D teams to develop new products and lead continuous quality improvement initiatives.
Review and disposition nonconforming material.
Support and advise regulatory teams on the review and writing of 510(k) submissions.
Participate in internal regulatory audits (FDA, notified body) as needed.
Maintain and improve internal SOP's / Work Instructions with respects to newly evolving and changing standards and regulatory environment.
Bachelor's Degree in Microbiology or related field with 5+ years' experience
Medical device experience; surgical medical device experience preferred
Project leadership skills
Knowledge of GLP & GMP requirements
Proficiency with Microsoft Office applications (Outlook, Word, Excel, Access, PowerPoint)
Strong communication skills, both verbal and written
Demonstrate a systematic approach in carrying out assignments
Good organizational skills
Proven ability to prioritize, conduct, and meet project deadlines